17 January 2019 - - The US Food and Drug Administration has accepted a Investigational New Drug application to evaluate the combination of Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) in patients with high-risk skin cancers, US-based immunotherapy drug development company NeoImmuneTech, Inc. and Genexine said.

This phase 1b/2a clinical study will be led by NeoImmuneTech and the Immune Oncology Network, a network of clinical research investigators from leading cancer centers and universities in North America that conducts multicenter trial of high priority immunotherapy agents.

The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of Hyleukin-7 in combination with Tecentriq in approximately 80 patients with anti-PD-(L)1 naïve or relapsed/refractory high-risk skin cancers. The planned multi-center open-label trial will be conducted in the US.

ION is headquartered at the Fred Hutchinson Cancer Research Center in Seattle Washington.

Hyleukin-7 TM (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 molecule, biologically fused with the proprietary long-acting platform hyFc. IL-7 is known to be a critical factor for T cells, acting to increase both the number and functionality of T cells.

Hyleukin-7 could play a pivotal role in reconstituting and reinvigoratiing T cell immunity in the treatment of patients with cancer and lymphopenia, as well as providing unique opportunities for immuno-oncology combination strategies.

Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine, Inc. (Genexine) are collaborating for clinical trials in advanced solid tumors, glioblastoma, etc. in the US and Korea.

NeoImmuneTech, a clinical-stage US biotech company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7, mainly in the US and EU.

NeoImmuneTech is currently conducting Phase 1b/2a clinical trials of Hyleukin-7, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy.